Novartis and Biological E agree to deliver affordable vaccines for typhoid and paratyphoid A fevers to developing world

NovartisNovartis today announced that it has entered into a development and licensing agreement with Biological E Limited (BioE), a biopharmaceutical company based in India, for two vaccines to protect against typhoid and paratyphoid fevers. The agreement advances the Novartis goal to deliver accessible and affordable vaccines that address unmet medical need in endemic regions.

In just five years, the Novartis Vaccines Institute for Global Health (NVGH), part of the Novartis Institutes for BioMedical Research, has developed a typhoid vaccine with funding by the Fondazione Monte dei Paschi di Siena and Regione Toscana through the Sclavo Vaccines Association (Italy). In addition, a dual-acting vaccine with components against both typhoid and paratyphoid fevers is being developed with on-going support from the Wellcome Trust. Both could reduce the burden of these diseases in endemic regions.

"NVGH uses its innovative know-how to tackle important problems in public health," said Don Ganem, VP and Global Head of Infectious Diseases, Novartis Institutes for BioMedical Research. "BioE has a proven track record in vaccine manufacture, and capabilities to clinically develop and deliver WHO pre-qualified affordable vaccines to the developing world. We are pleased to be working with them to address this unmet need."

More than 21 million cases of typhoid fever and five million cases of paratyphoid A fever are reported worldwide in a year[1], especially in areas that lack appropriate sanitation and access to clean water. Many victims are children under the age of two for whom there is no widely available typhoid vaccine, while no vaccine is available for any age group against paratyphoid fever.

Under the license, NVGH will transfer technology to BioE, which will have financial and operational responsibility for manufacturing, further clinical development, approval and distribution in the developing world. The typhoid vaccine (Vi-CRM197) has achieved Proof of Concept, had successful Phase 2 results, and will be transferred to BioE. A combined typhoid-paratyphoid vaccine will be transferred once Proof of Concept is completed through early, small-scale studies in humans to determine safety and immunogenicity. The Wellcome Trust continues to support the development of the dual-acting vaccine through a Strategic Award that was awarded in 2009.

"Typhoid and paratyphoid are major causes of life-threatening disease worldwide and with the emergence of resistance to all of the commonly used antibiotics, they are becoming increasingly difficult to treat," said Ted Bianco, Director of Technology Transfer and Acting Director of the Wellcome Trust. "This licensing deal takes us a step closer to getting much-needed affordable vaccines into the communities that need them most."

BioE is committed to achieving World Health Organization (WHO) pre-qualification and fulfill specific obligations to meet Novartis standards[2]. The agreement is worldwide except for developed countries, where Novartis will retain rights.

Information about typhoid and paratyphoid fevers
The bacteria Salmonella enterica serovar Typhi (S. Typhi) causes typhoid fever and is a significant public health problem in developing countries where access to clean water and proper sanitation is limited and causes over 21 million cases and over 200,000 deaths per year worldwide[1]. S. Paratyphi A causes a clinically similar disease (paratyphoid fever) and is reported to cause five million cases in a year[1]. Given limitations of current typhoid vaccines and increasing antibiotic drug resistance of the bacteria, there is an urgent need for effective vaccines.

About Novartis Vaccines Institute for Global Health
The mission of the Novartis Vaccines Institute for Global Health is to develop effective and affordable vaccines for neglected infectious diseases of impoverished communities. In striving to achieve this mission, NVGH aims to substantially reduce development risks and cost of new vaccines so that manufacturers will be able to viably produce and distribute these vaccines to the public health sector of the developing world. NVGH's role is to undertake the translational research required to take a laboratory concept through development to the human Proof of Concept and then to transfer this knowledge to a manufacturer.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in all these areas. In 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 129,000 full-time-equivalent associates and operate in more than 140 countries around the world.

1. Bulletin of the World Health Organization 2004; 82:346-353 (http://www.who.int/rpc/TFDisBurden.pdf)
2. http://www.novartis.com/downloads/corporate-responsibility/responsible-business-practices/10-principles.pdf

Most Popular Now

Top 20 breaking World Pharma News of 2017

We are proud to announce the top 20 most popular breaking World Pharma News from 2017. Have a wonderful 2018 new(s) year filled with health, happiness, and spectacular su...

Novartis advances head-to-head superiority trials …

Novartis announced today the initiation of SURPASS, a head-to-head clinical trial of Cosentyx® (secukinumab) versus proposed biosimilar adalimumab** in ankylosing spondyl...

New research paper shows that AstraZeneca has achi…

In a research paper published today by Nature Reviews Drug Discovery(1), AstraZeneca's IMED Biotech Unit documents a more than four-fold improvement in R&D productivity f...

Diabetes drug 'significantly reverses memory loss…

A drug developed for diabetes could be used to treat Alzheimer's after scientists found it "significantly reversed memory loss" in mice through a triple method of action...

Sandoz regulatory submission for proposed biosimil…

Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics Licen...

Zika remains a research and public health challeng…

Since 2016, when Zika was declared by the World Health Organization as a public health emergency of international concern, the virus has become established in more than 8...

Dirt-dwelling microbe produces potential anti-mela…

A type of soil-dwelling bacterium produces molecules that induce death in melanoma cells, research at Oregon State University shows. The molecule is a secondary metabolit...

Try exercise to improve memory, thinking

For patients with mild cognitive impairment, don't be surprised if your health care provider prescribes exercise rather than medication. A new guideline for medical pract...

FDA approves first treatment for breast cancer wit…

The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast can...

Novartis Kisqali® received FDA Breakthrough Therap…

Novartis today announced Kisqali® (ribociclib) received US Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pr...

Novartis appoints Elizabeth Barrett as Oncology He…

Novartis announced today that Elizabeth (Liz) Barrett, currently Global President Oncology at Pfizer, Inc., has been appointed CEO Novartis Oncology and a member of the E...

Berry gives boost to cervical cancer therapy

According to the Centers for Disease Control and Prevention, approximately 12,000 women in the United States are diagnosed with cervical cancer each year. One of the most...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]